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Meeting Speakers from the FDA
DIA 2022 is the only event where you can hear from executives at the FDA.
We are honored to have them partner so closely with us, especially at time where innovation has been catalyzed. Learn more below about these leaders of today.
Meet Confirmed Speakers from the FDA
Judith Arcidiacono, MS, International Regulatory Expert, Office of Tissues and Advanced Therapies, CBER
Judith received her B.S. in biology from West Virginia University in 1987, and M.S. in genetics from Clarion University. Her training in immunology includes course work at the National Institutes of Health Foundation for the Advancement of Education in the Sciences and the George Washington University.
Kassa Ayalew MD, MPH, Director, DCCE, OSI, Office of Compliance, CDER
Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with over several years of clinical and regulatory medicine experience.
Robert Ball MD, MPH, MSc, Deputy Director, Office of Surveillance and Epidemiology, CDER
Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug and biologic product safety and effectiveness using Real World Evidence, including managing the Sentinel System.
Robyn Bent, MS, RN, Director, Patient Focused Drug Development Program, OCD, CDER
Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn was a Chief Scientific Program Specialist at the National Institutes of Health. Captain Bent has extensive experience in clinical trial design, conduct, and oversight. Robyn earned a Bachelor of Science in Nursing from The Catholic University of America and a Master of Science degree from the George Washington University.
Jamie Brewer, Acting Clinical Team Lead, DO3, OOD, CDER
Jamie Brewer, MD, is a medical oncologist and Acting Clinical Team Lead in the Division of Oncology 3 (DO3) in the Office of Oncologic Diseases (OOD) at the Food and Drug Administration (FDA). Dr. Brewer joined the FDA in 2018 and previously served as a clinical reviewer on the Genitourinary Cancer team. Dr. Brewer serves as the Oncology Center of Excellence (OCE) Scientific Liaison for Cancer Disparities and is also a participant in multiple internal and external scientific and health equity working groups. Dr. Brewer completed her medical training at The University of Illinois at Chicago. She completed her residency and a joint fellowship in Medical Oncology and Clinical Pharmacology and Pharmacogenomics at The University of Chicago.
Keith Burkhart, MD
Dr. Burkhart received his medical toxicology training at the Rocky Mountain Poison Center in Denver. He received his Emergency Medicine training at the University of Cincinnati. He is the former Medical Director of the Penn State Poison Center. Clinical care has been provided at the PinnacleHealth Hospital. He is a co-editor of Critical Care Toxicology. He performs mechanistic-based biological plausibility consults for drug safety issues using cheminformatic and bioinformatic tools. Natural Language Processing is used to analyze the OVERDOSAGE Section of drug labels. Data mining is used to analyze real world evidence.
Michelle Campbell, PhD, Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a reviewer on the Clinical Outcome Assessments (COA) Staff and Scientific Coordinator of the COA Qualification Program in OND. Dr. Campbell’s focus is in patient-focused drug development and the use of patient experience data in the regulatory setting.
Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation
Dr. Cavazzoni received her medical degree at McGill University and completed a residency in Psychiatry and a fellowship in mood disorders at the University of Ottawa. She subsequently joined the faculty of medicine at the University of Ottawa as an assistant professor, where she was engaged in clinical work, teaching, and research on genetic predictors of mood disorders, authoring numerous peer-reviewed scientific publications. Following this, Dr. Cavazzoni worked in the pharmaceutical industry, held senior leadership positions in clinical development, regulatory affairs and safety surveillance.
Howard Chazin, MD, MBA, Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER
Dr. Chazin joined FDA in 2002 and has held several leadership positions related to clinical policy and safety of new drugs, biologics and generics. He is the Director of the Division of Clinical Safety and Surveillance in the Office of Generic Drugs' Office of Safety and Clinical Evaluation. He leads several multidisciplinary teams of physicians, pharmacists, nurses, and data analysts tasked with identifying and assessing emerging complex safety issues related to potentially inferior generic drug products and addressing all Risk Evaluation and Mitigation Strategies for generic drugs. He also provides oversight on assessment of critical aspects related to challenging, controversial and sensitive generic drug safety issues.
Ethan Chen MBA, Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics Architect, including Data Management and Business Intelligence programs. While leading the CDER Division of Data Management Service and Solution, Ethan had successfully implemented the eCTD electronic submission mandate in 2017 for NDAs, BLAs and ANDAs, and again in 2018 for Commercial INDs and DMFs (excluding DMF Type III). Ethan has over 20-years’ experience in Data Management, Enterprise Architecture, Solution Development and System Integration.
John Concato, MD, MPH, MS, Associate Director for Real-World Evidence Analytics, OMP, CDER
Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After conducting clinical research studies for more than 25 years as an independent investigator and research center director at Yale University & the Department of Veterans Affairs, he now develops, coordinates, and implements medical policy programs and strategic initiatives, with a focus on real-world evidence (RWE). His RWE-related efforts include consulting on submissions, helping to engage external stakeholders, and overseeing demonstration projects as well as guidance development in support of the agency’s evaluation of RWE.
Jacqueline Corrigan-Curay, JD, MD, Principal Deputy Director, Office of the Center Director, CDER
Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay leads the development, coordination, and implementation of medical policy programs and strategic initiatives, including policy development on real world evidence, drug labeling, prescription drug promotion, clinical trial oversight and innovative trial design. She works collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.
Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, OGROP
Director, Office of Pharmaceutical Quality Operations within FDA’s Office of Regulatory Affairs (ORA), responsible for all pharmaceutical quality inspections & investigations, both foreign & domestic, working in conjunction with FDA Centers: CDER and CVM. Alonza is also leading ORA’s efforts under the program alignment initiative, intended to facilitate operational and policy activities as FDA transitions to a distinct commodity-based and vertically-integrated pharmaceutical regulatory program.
R. Angelo De Claro, Associate Director, Global Clinical Sciences, OCE; Div Dir, DHM, OOD, CDER
Dr. de Claro is currently the Associate Director (Acting) for Global Clinical Sciences with US FDA Oncology Center of Excellence (OCE). In this role, he leads OCE efforts to advance cancer drug development and regulatory science across the globe, including direction of Project Orbis, a global collaborative review program started in 2019. Dr. de Claro is also the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. He is board certified in Internal Medicine, Hematology, and Medical Oncology.
Sai Dharmarajan, PhD Mathematical Statistician, OB, OTS, CDER
Sai is a Statistical Reviewer in the Division of Biometrics VII, Office of Biostatistics at CDER, where he joined in June 2018. As a reviewer, he supports the statistical review of over-the-counter drug product applications, epidemiological research projects and safety surveillance projects. His areas of specialization and interest include development and application of statistical methodologies for benefit risk assessment, causal inference using observational data, signal detection for safety surveillance and methods for electronic phenotyping.
William Dunn, MD
John Farley MD, MPH, Director, Office of Infectious Diseases, OND, CDER
Dr. John Farley is presently Director of the Office of Infectious Diseases in the Office of New Drugs at CDER, FDA. His office is responsible for the review of new antiviral and antibacterial drugs. In addition to new drug review work, Dr. Farley’s work at FDA has included implementation of the breakpoints provisions of the Cures Act, providing scientific leadership for establishment of the antimicrobial resistance focused regulatory science research program, and serving as a workstream lead for the Integrated Review as part of the Office of New Drugs Modernization. Prior to joining the FDA, Dr. Farley was on the faculty of the University of Maryland School of Medicine and focused care and research on perinatal HIV.
Lola Fashoyin-Aje, Associate Director, Science and Policy to Address Disparities, OCE
Lola A. Fashoyin-Aje, MD, MPH, is a medical oncologist and Deputy Division Director in the Division of Oncology 3 (DO3) in the Office of Oncologic Diseases (OOD) at the Food and Drug Administration (FDA). At the FDA, Dr. Fashoyin-Aje has served as clinical reviewer in the Gastrointestinal (GI) Malignancies team, and as team leader for the Breast Malignancies, Melanoma and Sarcoma, and Gastrointestinal Malignancies clinical teams. In her current role, she provides scientific and policy guidance and oversight to multidisciplinary teams reviewing drugs and biologics under development for the treatment of solid tumor (GI, sarcoma, melanoma) malignancies. She has also served as the Oncology Center of Excellence (OCE) Scientific Liaison for Cancer Disparities and in this role, has led the OCE’s efforts to improve inclusion of diverse demographic subgroups in clinical trials and participates in several internal and external scientific and policy working groups. Dr. Fashoyin-Aje also serves on the ASCO Health Equity Committee, the AACR Science of Cancer Health Disparities Scientific Program and Scientific Review committees, and the ASCO Cancer Research Committee.
Prior to joining the FDA, Dr. Fashoyin-Aje completed her residency in internal medicine and fellowship in medical oncology at Johns Hopkins. She completed her undergraduate and graduate training at Columbia University and Yale University, respectively, and earned her medical degree from the University of Rochester.
Richard Forshee, PhD, Deputy Director, OBPV CBER
Richard Forshee is the Deputy Director for the Office of Biostatistics and Pharmacovigilance in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood products, vaccines, and human cell and tissue products. Before joining the FDA, he was the Director of the Center for Food, Nutrition, and Agriculture Policy at the University of Maryland, College Park.
Priyanka Ghosh, PhD, Acting Team Lead, ORS, Office of Generic Drugs, CDER
Dr. Priyanka Ghosh is a pharmacologist within the Office of Generic Drugs, US FDA. Her specialization is drug products in the topical and transdermal drug delivery area. In her current role, Dr. Ghosh is responsible for the development of regulatory standards for complex generic dosage forms. Prior to joining the FDA, Dr. Ghosh completed her B.Tech in Biotechnology from West Bengal University of Technology (India) and a Ph.D. in Pharmaceutics and Drug design from the University of Kentucky. Dr. Ghosh is also the author on numerous research manuscripts and review articles in the topical and transdermal area.
Susanne Goldstein, MD, Medical Officer, ON, Office of New Drugs, CDER
Susan is is a Mathematical Statistician reviewer in CDER, assigned to pulmonary, allergy and critical care indications. She became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG, which lead to subsequent interests in safety graphics, and use of estimands and benefit-risk for structured thinking and assessment. Her goal is to use quantitative thinking and methods in the ever-evolving field of safety assessment and benefit-risk evaluation during drug development, and to use estimands to align the data assessment with the clinical objectives of the program, for making quality, data-informed decisions based on what's best for patients.
Ann Meeker-O’Connell, MS, Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy (OCLiP) in the Office of the Commissioner. In this role, she leads an organization that coordinates the development of human subject protection and good clinical practice policy across the agency. Ms. Meeker-O’Connell has more than 20 years of experience in biomedical research and development in government, academic, and industry settings, including prior FDA service as the Acting Director of the Division of Good Clinical Practice Compliance in CDER. Ann earned her MS in Pharmacology, and was an NIH Integrated Toxicology Fellow, at Duke University.
Edward Millikan, PharmD, RPh, Senior Informatics Pharmacist, OMEPRM, OSE, CDER
Ed Millikan, PharmD, is the Senior Informatics Pharmacist in the Division of Mitigation Assessment and Medication Error Surveillance, Office of Surveillance and Epidemiology (OSE), in FDA’s Center for Drug Evaluation and Research. With over 20 years of experience as an Informatics Pharmacist, his background includes: REMS, drug information database development, healthcare terminologies (e.g., NLM RxNorm, SNOMED CT) and data standards (e.g., NCPDP SCRIPT, HL7® FHIR®), interoperability, and coding.
Dr. Millikan graduated magna cum laude from the Campbell University School of Pharmacy and completed a residency in Drug Information and Pharmaceutical Informatics at the University of California, San Francisco and First Databank.
Jean Mulinde, MD, Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in OND. She received her M.D. and completed a residency in Internal Medicine at the University Of South Alabama School Of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine.
Theresa Mullin, PhD, Associate Director for Strategic Initiatives, CDER
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations for 2017 reauthorization of the Prescription Drug User Fee Act and also led the 2002, 2007 and 2012 PDUFA reauthorization cycles providing $1B in annual funding. She received the 2019 Reagan-Udall Foundation Leadership Award for Innovations in Regulatory Science, US Food and Drug Law Institute 2017 Distinguished Service and Leadership Award, 2011 Presidential Rank Award for Distinguished Service, for Meritorious Service in 2006.
George Neyarapally JD, PharmD, MPH, Regulatory Science Research Policy Lead, Regulatory Science Staff, OSE, CDER
George Neyarapally, PharmD, JD, MPH, RPh works as a subject matter expert at the FDA in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER) on regulatory science and policy initiatives and research. George previously worked at MITRE/the Health Federally Funded Research and Development Center for the U.S. Department of Health and Human Services (HHS), as a Medicaid Pharmacy Director, in HHS at the FDA, AHRQ, and OS/ASPR, as a Congressional Health Fellow in the U.S. Senate, and as a drug information and safety pharmacist.
Richard Pazdur, MD, Director, Oncology Center of Excellence
Richard Pazdur, M.D., is the director of the FDA’s Oncology Center of Excellence (OCE), which leverages the combined skills of FDA’s regulatory scientists and reviewers with expertise in drugs, biologics, and devices to expedite the development of novel cancer products. In this role, Dr. Pazdur is responsible for leading the effort to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review.
Dionne Price, PhD, Deputy Director, Office of Biostatistics, OTS, CDER
Dr. Price is the Deputy Director of the Office of Biostatistics. In her role at FDA, she promotes collaborative efforts to advance the use of complex innovative trial designs. An invited speaker at conferences world-wide, she has served as Chair of ASA’s Biopharmaceutical Section and on the Regional Committee of the Eastern North American Region of IBS. She is a Fellow of the ASA and the President-Elect of the ASA. With an MS in Biostatistics from UNC, and PhD from Emory, her research interests focus on clinical trial designs. She has co-authored papers in Statistics in Medicine, Clinical Trials, and Statistics in Biopharmaceutical Research.
Sam Raney, PhD, MS, Associate Director for Science, ORS, Office of Generic Drugs, CDER
Dr. Sam Raney is a thought leader in topical and transdermal drug products, with over 25 years of experience as an academic researcher, an adjunct professor, and a principal or sub investigator on over 400 studies. He has authored numerous research manuscripts, review articles, book chapters and patents related to pharmaceutical product development, lectured globally, and held senior management roles in industry. He is the Lead for Topical and Transdermal Drug Products in the FDA Office of Generic Drugs and is an expert panel member in the U.S. Pharmacopeia. Dr. Raney holds a B.A. in Molecular Biophysics & Biochemistry from Yale University, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada.
Donna Rivera, PharmD, MSc, Associate Director for Pharmacoepidemiology, OCE
Donna R. Rivera, PharmD., MSc., is the Associate Director of Pharmacoepidemiology in the Oncology Center of Excellence at the US Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the use of Real World Data (RWD) and RWE for regulatory purposes as well as management of the RWD research portfolio strategy and development of related regulatory policy to support the OCE mission. Dr. Rivera has interests in the use of RWD to increase knowledge of unrepresented populations and advance health equity, observational study designs and RWD methodological approaches, and appropriate uses of RWD for drug development to increase access of effective therapies to patients.
Leonard Sacks, MD, Associate Director for Clinical Methodology, Office of Medical Policy, CDER
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently as a reviewer at FDA. He is a clinician, board certified in Internal Medicine and Infectious Diseases.
Leyla Sahin, MD, Acting Deputy Director for Safety, DPMH, OND, CDER
Dr. Sahin is an ob/gyn who is the Acting Deputy Director for Safety in the Division of Pediatrics and Maternal Health in the Office of New Drugs in CDER. She has led various maternal health related scientific and regulatory/policy initiatives. She was a working group member on the HHS Task Force for Research Specific to Pregnant Women and Lactating Women (PRGLAC). The focus of her work involves providing pregnancy and lactation scientific and regulatory expertise to the review divisions in the Office of New Drugs, through all phases of drug development. Her principal area of interest is promoting the public health of pregnant and breastfeeding individuals through improved data collection.
John Scott, PhD, MA, Director, Division of Biostatistics, OBPV, CBER
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College, and is a Fellow of the American Statistical Association.
Jenn Sellers, MD, PhD, Senior Medical Officer, OSI, OC, CDER
Dr. Sellers is a board-certified pediatrician working as a senior medical officer at Good Clinical Practice Assessment Branch in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. She has clinical experience for over 20 years. She also holds a Ph.D. in computational biology and bioinformatics in University of Maryland studying how single nucleotide polymorphisms (SNPs) cause protein structure and function changes and cause genetic disorders.
Haley Seymour, MS, Consumer Safety Officer, OSI, OC, CDER
Haley Seymour earned her Bachelor of Science degree from Howard University in Clinical Laboratory Science and her Master of Science in Bioscience Regulatory Affairs from Johns Hopkins University. She joined the Food and Drug Administration (FDA) in 2009 as a Regulatory Project Manager for the Office of New Drugs, Division of Endocrinology and Metabolic Products. Currently she is a Consumer Safety Officer for the Risk Evaluation and Mitigation Strategies (REMS) Compliance Team in the Division of Enforcement and Post marketing Safety (DEPS). She has represented DEPS and the FDA in several outreach programs, communicating with a number of internal and external stakeholders, and lectured on topics related to REMS Compliance.
Mary Ann Slack, Director, Office of Strategic Programs, CDER
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in many of the Center’s strategic initiatives including decision support, data standards, program analysis, IT, informatics, and governance. Ms. Slack serves on several Boards and Committees where she supports FDA’s needs and perspectives.
James Smith, Deputy Director of the Office of New Drug Policy, OND, CDER
Dr. Smith is deputy director of the Office of New Drug Policy in the Office of New Drugs (OND), with his primary focus being clinical and scientific policy priorities. He was formerly deputy division director of the Division of Metabolism and Endocrinology Products, overseeing development programs targeting diseases ranging from the very rare to the very common. Dr. Smith is a graduate of the University of Michigan Medical School and completed an Internal Medicine residency at the same institution before fellowships in both nephrology and clinical pharmacology at Vanderbilt University Medical Center. He also holds a master's degree in Clinical Research Design and Statistical Analysis from the University of Michigan School of Public Health.
Mat Soukup, PhD, Deputy Director, Division of Biometrics VII, OB, OTS CDER
Following his educational endeavors in statistics at the University of Minnesota-Morris and the University of Virginia, Mat joined FDA/CDER in September 2004. His first 6 years were spent reviewing dermatology and dental products before joining the Division of Biometrics 7 as Team Lead and later as Deputy Division Director. In these roles, Mat is involved in the quantitative assessment of safety covering a spectrum of statistical issues ranging from retrospective assessment of safety signals to prospective design of safety outcome trials.
Sam Raney PhD, MS, Associate Director for Science, ORS, Office of Generic Drugs, CDER
Dr. Sam Raney is a thought leader in topical and transdermal drug products, with over 25 years of experience as an academic researcher, an adjunct professor, and a principal or sub investigator on over 400 studies. He has authored numerous research manuscripts, review articles, book chapters and patents related to pharmaceutical product development, lectured globally, and held senior management roles in industry. He is the Lead for Topical and Transdermal Drug Products in the FDA Office of Generic Drugs, and is an expert panel member in the U.S. Pharmacopeia. Dr. Raney holds a B.A. in Molecular Biophysics & Biochemistry from Yale University, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada.
Donna Rivera, PharmD, MSc, Associate Director for Pharmacoepidemiology, OCE
Donna R. Rivera, PharmD., MSc., is the Associate Director of Pharmacoepidemiology in the Oncology Center of Excellence at the US Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the use of Real-World Data (RWD) and RWE for regulatory purposes as well as management of the RWD research portfolio strategy and development of related regulatory policy to support the OCE mission. Dr. Rivera has interests in the use of RWD to increase knowledge of unrepresented populations and advance health equity, observational study designs and RWD methodological approaches, and appropriate uses of RWD for drug development to increase access of effective therapies to patients.
Leonard Sacks, MD, Associate Director for Clinical Methodology, Office of Medical Policy, CDER
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently as a reviewer at FDA. He is a clinician, board certified in Internal Medicine and Infectious Diseases.
Jenn Sellers, MD, PhD, Senior Medical Officer, OSI, OC, CDER
Dr. Sellers is a board certified pediatrician working as a senior medical officer at Good Clinical Practice Assessment Branch in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. She has clinical experience for over 20 years. She also holds a Ph.D. in computational biology and bioinformatics in University of Maryland studying how single nucleotide polymorphisms (SNPs) cause protein structure and function changes and cause genetic disorders.
Haley Seymour, MS
Dr. Sellers is a board certified pediatrician working as a senior medical officer at Good Clinical Practice Assessment Branch in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. She has clinical experience for over 20 years. She also holds a Ph.D. in computational biology and bioinformatics in University of Maryland studying how single nucleotide polymorphisms (SNPs) cause protein structure and function changes and cause genetic disorders.
Mary Thanh Hai, Med, MD, Deputy Director for Clinical, OND, CDER
Dr. Thanh Hai is an internist/endocrinologist receiving her medical degree from Georgetown University. She joined the FDA in 1998 as a medical reviewer in the Division of Metabolism and Endocrinology Products (DMEP) in the Office of New Drugs. From 2006-2013, she served as the Division Director for DMEP, which oversaw development programs for dyslipidemia, diabetes, obesity, and general endocrinology diseases. From 2013-2018 she was the Deputy Office Director for the Office of Drug Evaluation 2 overseeing three review divisions covering therapeutics for endocrine, pulmonary, rheumatology, analgesics, anesthesia, and addiction disorders. She is currently the Deputy Director for Clinical in the Office of New Drugs, Immediate Office.
Graham Thomson, Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER
Graham Thompson joined FDA in 2012 and currently serves as an operations research analyst for the Decision Support and Analysis Team (DSAT) in FDA’s Center for Drug Evaluation and Research (CDER). He works on CDER projects and initiatives related to benefit-risk assessment and supporting programmatic and regulatory decisions. With DSAT, he is a co-lead for guidance development as well as advancing benefit-risk assessment and decision analysis methodologies. Graham has previously worked on CDER’s various Patient-Focused Drug Development initiatives and efforts to facilitate the incorporation of patient input into decision-making. Graham also has experience working on PDUFA negotiations and other strategic, regulatory, and policy efforts.
Katherine Tyner, PhD, FDA Liaison to the EMA, Office of Global Policy and Strategy, OC
Dr. Katherine Tyner is the FDA liaison to the EMA. Dr. Tyner joined FDA in 2007 and has held numerous positions within CDER to advance the quality, safety, and efficacy of complex drug products. In her most recent role as the Associate Director for Science in the Office of Pharmaceutical Quality (OPQ), Dr. Tyner led the OPQ Science Staff in coordinating the intersection between science, review, and policy as well as facilitating interactions among FDA Centers and Offices. Prior to her appointment as liaison, Dr. Tyner was in the Office of Science and Technology Policy within the Executive Office of the President working on efforts to increase technology transfer across the research, development, and deployment continuum.
John Weiner, JD, Associate Director for Policy, Office of Combination Products, OCPP, OC
John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of medical products (drugs, devices, biological products, and combination products).
Hong Yang, PhD, Biologist, OBPV, CBER
Dr. Hong Yang is a senior advisor for benefit-risk assessment in OBPV/CBER/FDA. She holds Ph.D. degree in Biological Engineering. Dr. Yang has expertise in benefit-risk assessment of biological products and Modeling and Simulation to inform drug development. She has been devoted in regulatory review, as well as research, training, and outreach activities for novel approaches to benefit-risk assessment. She led many benefit-risk assessments to inform FDA regulatory decision and participated development of guidance for industry. She is a member of several FDA, HHS, WHO, CIOMS and ASA working groups on benefit-risk assessment of medical products.
Lynne Yao, MD, Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatrics and Maternal Health oversees quality initiatives within the Office of New Drugs that promote and necessitate the study of drug and biological products in the pediatric population and improve pregnancy and lactation-related information in product labeling.
Di Zhang, PhD, Statistical Reviewer, OB, OTS, CDER
Di Zhang, Ph.D., is a Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. She holds a Ph.D. degree in Biostatistics from the University of Pittsburgh. Di specializes in causal inference using real-world data and leveraging real-world evidence in clinical studies. She oversees several FDA funded projects for drug safety signal detection using real-world data.
Yueqin Zhao, PhD, Lead Mathematical Statistician, OB, OTS, CDER
Yueqin Zhao is a lead mathematical statistician in Office of Biostatistics, Center for Drug Evaluation and Research, FDA. Her research interests include benefit-risk assessment, signal detection, and statistical methods in observational studies.
Ahmed Zidan PhD, MS, Senior Staff Fellow (Pharmacologist), OTR, OPQ, CDER
Dr. Ahmed Zidan is a senior pharmacologist staff in the Division of Product Quality Research of Office of Testing and Research of CDER. Ahmed leads the topical and transdermal drug products laboratories of DPQR. Dr. Zidan leads the regulatory science research related to topical and transdermal drug products of OPQ. Ahmed is also an FDA-USP liaison of complex excipients Expert Committee. Ahmed’s research activities and collaborations produced over 100 publications and 3 book chapter. Prior joining FDA, Dr. Zidan was a professor of Pharmaceutics at Zagazig University, Egypt. Ahmed completed his bachelor’s degree in pharmacy and master’s degree in Zagazig University, and his doctoral degree in Drug Delivery Howard University, Washington DC.
Craig Zinderman MD, MPH, Associate Director for Product Safety, Division of Epidemiology, CBER
Dr. Zinderman has worked in the Division of Epidemiology in the Office of Biostatistics and Pharmacovigilance (OBPV) since 2004. He initially served as a Medical Officer and Epidemiologist in the Therapeutics and Blood Safety Branch for 4 years, before becoming the Acting Branch Chief in 2008. From 2012 to 2020, Dr. Zinderman served as the Associate Director for Product Safety, in the Division of Epidemiology. He currently serves as the Associate Director for Medical Policy in OBPV. Prior to joining FDA, Dr. Zinderman served as a Preventive Medicine Officer in the US Navy. He is Board certified in General Public Health and Preventive Medicine.
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